Reversing heart disease risk the HARD way

Numbers Game

Call it “blinders therapy.” Load a patient up with high doses of powerful drugs for three years, and when you see the faintest glimmer of positive results, call it a success and pop the corks for a celebration.

And what about serious adverse side effects? That’s what the blinders are for.

Long-term outcomes in a haze

It almost reads like a parody of mainstream medical practice…

Your patient with type 2 diabetes has atherosclerosis (narrowing of the arteries). Solution? Simply pour on the cholesterol-lowering statins and ACE inhibitors in an attempt to get the numbers you want: lower LDL and lower BP.

Unfortunately, you’re treating a human being, not a compilation of numbers.

But don’t bother telling that to the National Heart, Lung and Blood Institute (NHLBI) – a division of the National Institutes of Health. NHLBI funded a relatively new trial called SANDS (Stop Atherosclerosis in Native Diabetics Study), which set out to answer the question: Can atherosclerosis be stopped or reversed when the condition is attacked with high drug doses?

STUDY PROFILE:
* Researchers recruited 500 American Indians: each subject was over the age of forty, had type 2 diabetes, high cholesterol, and high blood pressure
* Subjects were divided into two groups: one group aimed to reach “standard” recommended LDL cholesterol and blood pressure targets, and one group was “aggressive” in aiming for substantially lower targets
* For three years, study clinicians examined each subject once every three months, adjusting doses of statin drugs and blood pressure drugs as needed in order to reach standard or aggressive targets
* Ultrasound was used to track atherosclerosis in each subjects’ carotid arteries

Results: Subjects in both groups met their standard or aggressive targets. Atherosclerosis decreased in the aggressive group, but actually increased in the standard group. Rates of cardiovascular disease events (such as heart attack) were about the same in both groups.

Let’s not fail to put the spotlight on one very revealing detail: About 250 type 2 diabetics with high cholesterol followed a standard statin drug regimen for three years, and their atherosclerosis progression didn’t stop, it ADVANCED. If I’m diabetic and my doctor has convinced me to sign on for a lifetime of statin use, that’s not quite the outcome I would hope for.

As for adverse side effects, here’s how the SANDS authors summed up the risk-benefit ratio in JAMA: “The lack of difference in occurrence of events and the increase in adverse events and serious adverse events attributable to the BP lowering raise the possibility that there may not be favorable long-term outcomes.”

But don’t think NHLBI officials will let a little thing like THAT spoil their party!

Follow the money

Here’s the headline Reuters news service went with in reporting SANDS results: “Drug Regime Reverses Heart Disease Risk.” And that’s quite true as long as you completely ignore the details.

Dr. Elizabeth Nabel, NHLBI director, gave Reuters this shiny bright load of happy-talk: “For the first time, we have evidence that aggressively lowering LDL cholesterol and blood pressure can actually reverse damage to the arteries in middle-aged adults with diabetes.”

Of course, Dr. Nabel is well aware that a patient must commit to a lifetime regimen of very high doses of statin drugs in order to push LDL levels as low as they went in the SANDS trial.

Way to promote those statins, Dr. Nabel!

An NHLBI press release also offered this quote from the lead author of the study, Barbara V. Howard, Ph.D.: “Our message to doctors, nurses, and patients is that you can reach your goal levels, and we should work together to help you do that.” In other words: In spite of the clear warning at the end of her own study, Dr. Howard seems to believe we should work together to sign you up for the mega-statin lifetime plan.

And to put things into perspective, we’ll finish up with this note from MedPage Today: Dr. Howard reported serving on the advisory board of Merck. Merck makes Zocor. Zocor was the statin used in the SANDS trial.

With friends like these, diabetics don’t need enemies.

Sources:
“Effect of Lower Targets for Blood Pressure and LDL Cholesterol on Atherosclerosis in Diabetes” Journal of the American Medical Association, Vol. 299, No. 14, 4/9/08, jama.ama-assn.org
“Cholesterol, Blood Pressure Control May Reverse Atherosclerosis in Adults With Diabetes” National Heart, Lung and Blood Institute press release, 4/8/08, eurekalert.org
“Drug Regime Reverses Heart Disease in Diabetics” Andrew Stern, Reuters, 4/8/08, reuters.com
“Mixed Results with Aggressive Risk Reduction in Diabetic Patients” Charles Bankhead, MedPage Today, 4/8/08, medpagetoday.com